Evaluation: Medtronic Situate Detection System X Surgical Sponge Detection Technology

June 13, 2018 | Evaluations & Guidance


  • The device is designed for RF detection of surgical soft goods in both the patient and the OR before surgical closure and in the event of a count discrepancy or a misplaced sponge.
  • Major device components and software features:
    • Situate Detection System X Console (previously known as the RF Assure Console 200X)
      • Seven-pound console intended for placement on an OR boom or cart. The console features non-interchangeable quick-connect-type outlets for the body scanner and other detection accessories (i.e., room and extremity scanners).
        • The console has an Ethernet port and several USB connections for accessing data logs, which can tell interested parties the quantity and results of scans, accessory type, scan duration, and result of all scans from a procedure using that specific console.
        • Since these logs are time-stamped, ECRI Institute recommends that your facility's biomedical engineering department updates the internal clock to account for the start and end of daylight saving time.
      • All scanning is initiated using touchscreen button presses on the console. ECRI Institute recommends that users scan patients before closure regardless of whether a manual count is discrepant, due to the risk of manual counting errors.
        • In the event of a detection: The user sees a red screen with an "X," which continues to a detection code, identifiable as it ends in the letter "D" (e.g., 17905-79D).
        • In the event of a clear scan: The user sees a green screen with a check mark, which continues to a clear code, identifiable as it ends in the letter "C" (e.g., 11103-2C). ECRI Institute recommends making entry of this clear code a mandatory field in your patient's electronic medical record. Closing a cavity prior to receiving a clear code at the console may invite risk of a retained sponge.
    • Situate Body Scanner Lite (previously known as the ConformPlus II Detection Mat)
      • Four-pound foam mat intended to lie beneath the draped patient's abdominal area (dimensions are 42 × 20 × 1 in). The mat has an array of six antennae that successively scan the area encompassing approximately 16 inches above the mat. Users cannot interrupt the mat scan, which requires approximately 17 seconds.
      • The console will default to scanning with the detection mat if multiple accessories (i.e., the mat and one of the scanning wands) are plugged into it.
      • The detection mat may require annual replacement. If a mat is damaged within a procedure (e.g., bent such that it yields a fault code, or accidentally cut), it should be replaced immediately.
    • Situate RF-tagged surgical soft goods (RFDetect Premium, Situate Sponges)
      • Medtronic surgical soft goods (laparotomy sponges, gauze, towels, packing, etc.) are available sterile or nonsterile in a variety of dimensions and thicknesses, with a radiopaque element for x-ray detection in the event that an x-ray scan is required. A small, cylindrical, passive RF tag is sewn into the sponge in a corner pocket. Most are available in packs of five or 10 and often purchased as part of a surgical kit.
      • If your facility chooses to employ the Situate (or any other technological adjunct to manual counting), ECRI Institute recommends switching all applicable surgical soft goods over to those that are appropriately tagged to reduce the risk of accidentally using a sponge not compatible with the system.
  • Consoles are situated outside the sterile field of ORs. The detection mat is beneath the draped patient, and room and extremity scanners should be covered with a sterile drape for use within the sterile field. The device is typically used for any procedures requiring the use of surgical soft goods, including: a) Abdominal surgery

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